The present invention refers to a device and a procedure for joining hollow organs. With devices and procedures of this kind for attaching blood vessels, the suturing process, for example, can be mechanized and consequently speeded up and simplified. This is of great importance in coronary surgery, in particular for performing operations on the beating heart. Furthermore, through the use of devices and procedures of this kind a repeatable and high-quality suturing process can be carried out, so that the risk of the vessels not being leak-free is minimized or, for example, in coronary surgery that the rear wall of the blood vessel in question is also attached.
An important area of application for devices and procedures of this kind is the suturing of end-to-side anastomoses in coronary by-pass surgery, i.e. surgically applied unions of hollow organs in which one end of a vessel is sewn laterally to another one. The devices and procedures under the invention can, however, be used for sewing vessels in all other areas of vascular surgery.
Today, about 70,000 by-pass operations are performed each year in Germany alone. Anastomoses on the coronary arteries are the most difficult discipline. They require a great deal of skill and experience on the part of the surgeon, because the blood vessels here are extremely small, with an average arterial diameter of 2 mm and an average vascular diameter of 4 mm, and where the diameter of the other transplants, arteria mammaria interna, for example, is often only 2 mm. In particular, there cannot be any leakage or attachment of the rear wall of the vessel.
The manual procedure can be divided up into the following operational steps, where the attachment at the anastomosis suture represents the task which can be taken over by mechanical devices and the appropriate procedures. First of all, a thoracotomy and a sternotomy (opening and separation of the chest wall) are performed. Parallel to this, the transplant (e.g. vein) is obtained and prepared for attachment to the artery with a suitable diagonal end cut. In the next step, an incision is made into the artery as a lengthwise opening. Next the openings of the vein and the artery are joined to each other. This can be simplified and improved by means of a mechanical device. Finally, the thorax is closed up again.
Under the present art, several types of what are called staplers are currently known, which, like a paper stapler, place a clip instead of a suture. The systems are used primarily for larger vessels or for sealing off open vessels. Leaks in particular are a major problem with end-to-side staplers. Staplers of this kind are known, for example, from U.S. Pat. Nos. 5,732,872, 4,930,674 or 5,285,945.
Coupling systems, such as those described in xe2x80x9cReview of Facilitated Approaches to Vascular Anastomosis Surgery,xe2x80x9d Werker, P. et al., The Society of Thoracic Surgeons, 1997, follow another approach to joining vessels. Coupling systems of this kind are used mostly in the intestine, or to join the blood vessels end-to-end.
A third group of procedures for connecting vessels is based on the conventional suturing technique, which has been mechanized. A system of this kind, for example, is the ArthroSew(trademark) Suturing System from U.S. Surgical Dynamics.
The disadvantage of all these systems known from the present art is that they often do not provide any possibility for end-to-side anastomosis, or are not suitable for small vessels with a diameter of about 2 mm. In particular, they are often also not suitable for by-pass surgery.
Other applications of the present invention will become apparent to those skilled in the art when the following description of the best mode contemplated for practicing the invention is read in conjunction with the accompanying drawings.
It is, therefore, the object of the present invention to make available a procedure and a device for closing an opening in a blood vessel or for joining hollow organs, in particular for performing anastomoses, with which two hollow organs can be joined in a way that is simple, safe and of high quality, as well as being repeatable.
This task is solved by means of the device in accordance with the invention.
With the device according to the invention or the procedure according to the invention, both proximal as well as distal anastomoses can be performed in a coronary artery bypass operation (CABG), as well as anastomoses with the arteria mammaria interna as the transplant. In addition, they can be employed for closing (sewing up) a blood vessel.
The fundamental operating principle of the device under the invention and the procedure under the invention is based on simultaneously punching several needles with sutures through a vessel, where there are similar needles at the other end of the suture, which are simultaneously punched through a second vessel. By pulling the ends of the two sutures tight, placing the ends of the sutures in the cradle and tying the ends of the sutures together, the two vessels are then securely attached to each other.
This conception of the device and the procedure solves the task of joining hollow organs, specifically performing anastomoses in a simple, safe and repeatable way. The primary field of application is by-pass surgery on the heart with coronary ischemia, but in addition operations on other organs in the case of stenoses, occlusions, strictures and thromboses, for example, in peripheral arteries.
In contrast to manual attachment or the conventional procedures, there is no risk of the rear wall of the vessel being attached or the anastomosis suffering from leakage. With the device under the invention and the procedure under the invention, most operations can not only be performed on the asystolic heart, so that any additional traumatization for the patient as the result of the use of the heart-lung machine is avoided. Specifically, the attachment of very small vessels with a diameter of about 2 mm is possible in safety.
On the basis of the mechanized suturing process, the quality of the suture is improved, the rear wall is protected, for example, by means of a needle carrier designed as a shoe, and the operation can consequently be carried out in most cases on the beating heart.
Under the invention, the device for joining hollow organs has several elements, which are an elongated holder a needle carrier, which is located at one end of the holder, where the needle carrier forming a projecting overhang extends radially beyond the elongated holder, so that a plurality of needles can be disposed in a ring on this projection pointing away from the end of the holder, for example, so that they stand vertical, while their ends are connected to sutures. In this way, the needle carrier is constructed as a shoe, which protects the rear wall of the vessel from the needles when the holder is inserted into the incision in the vessel. The needles can then be splayed out at a predetermined angle and, with the assistance of a needle seat positioned on the outside of the vessel wall, pushed through the vessel wall along the circumference of the incision.
If the other side of the sutures is connected with needles in a similar carrier, the second vessel which is to be connected to the first one can be sutured in this way along the periphery of its incision, so that the two openings are joined along their circumference when the sutures are subsequently pulled tight and tied together. With this, both hollow organs are securely joined together with their openings flush and in a sealing manner.
The holder can be implemented as a table stand, for example, for the end of a transplant, if the transplant is still unattached, or as a handle for example, for the second end of the transplant or for the mammaria. In addition, the holder can be equipped with an insertion aid for the transplant, for example, the vessel undergoing anastomosis. This insertion aid can be an enlargement of the elongated holder, or be mounted in the elongated holder in such a way that after the transplant is pulled over the holder and the insertion aid, this insertion aid is expanded so that the transplant has a larger circumference. In this way the transplant can be expanded to a circumference which extends beyond the periphery of the array of needles, so that by means of axial movement in the direction of the holder, the needles can be then pushed through the vessel wall of the transplant.
Instead of being pulled over an insertion aid, the holder can also be connected to a sleeve, for example, a cylindrical hollow body. The sleeve can be furnished with a suction device. When the transplant is inserted/introduced into the sleeve, its outer wall is pulled against the inner wall of the sleeve by suction and held in position there.
In the next step the end of the transplant is cut to shape. To do this, the sleeve can have a cutting surface which is a surface not oriented parallel to the direction of its internal passage, for example perpendicular or diagonally at a predetermined angle.
Set off from this cutting surface, the sleeve has adjustable pressure pads along its circumference by means of which the transplant can be squeezed together. Then the transplant has a larger cross section in the area of the cutting surface than in the area of the pressure pads and it narrows down in the transition to the area of the pressure pads, for example, like a funnel.
If the diameter of the needle array is selected in such a way that it lies between the diameter of the two cross sections, the needles can be moved in the direction of the transplant in the axial direction of the sleeve, starting from the inside of the transplant, until they push through the wall of the transplant in the funnel-shaped area and they can be located on the outside of the transplant by a needle seat.
Since only the outside of the transplant is touching the inside of the sleeve, the endothelial layers on the inside of the transplant cannot be damaged. Consequently, both distal as well as proximal anastomoses can be performed, as well as anastomoses with the mammaria.
With respect to the artery also, it can be held by annular suction by means of a suction device before the incision is made. Kept in position like this, the incision is then made inside the suction-held area at a length matching the circumference of the transplant, and then the shoe with the needles is inserted, without the possibility that the arterial walls could collapse into the artery after performing the incision.
To protect the needles when they are being inserted, or rather to protect the vessel from the needles, a needle cap can be pulled over the needles and the needle tips, which is removed from the needles immediately before the needles are deployed, or before the needles are pushed through the vessel wall. In this way, the vessel is protected for as long as possible from the sharp-pointed needles and injuries resulting from them.
The needles can be extended in the direction of the lateral vessel wall immediately before being pushed through the vessel wall, while a sleeve is inserted between the needles and the elongated holder and the needles are splayed outwards.
All the movements of the needle cap or the sleeve, for example, or the two-part seat for pushing the needles through the vessel wall, can be carried out by simply pressing buttons, for example by using a handle which is attached to the holder and has the appropriate controls with mechanical means of movement.
Once the two openings of the vessels are sutured and the sutures drawn tight, the needle seats with the needles and the sutures attached to them can be placed in a cradle, where as the result of proper design of the cradle and proper placement of the needle seats, the sutures coming from the transplant or from the artery are correctly sorted out automatically. The matching ends of the sutures can then be tied together correctly.
Tying the sutures together can be done, for example, by means of an auxiliary instrument which takes up the parallel sutures in the cradle from the two sides (artery, transplant) and encloses them with clips. The auxiliary instrument can be designed in such a way that several clips can be placed simultaneously, or only one clip is placed at a time. If several clips are placed simultaneously, it is advantageous if the end effector of the auxiliary instrument is designed in such a way that the distance between the clips on the auxiliary instrument is equal to the distance between the sutures in the cradle.
As an alternative to the auxiliary instrument, conventional knots can continue to be made or other procedures such as bonding, thermal forming, etc. can continue to be used. In addition, clips made of nitinol, such as those produced by the Coalescent Surgical Co. Inc., can be used to join the sutures coming from the two hollow organs.
In addition to straight needles, curved needles are also conceivable.
For sewing on a arteria mammaria interna (an artery which is already on the heart and is only being sutured unilaterally), it is conceivable to design the instrument as a minimally invasive surgical instrument and to introduce it into the body through small incisions and to suture without opening the sternum. To do this, the part of the instrument for the artery and the transplant side would be introduced into the body by means of a trocar and handled endoscopically.
The handles of the tool can also be designed in such a way that they can be manipulated by a robot. In the first step, the procedure for the transplant could continue to be performed by hand and only the procedure for the artery be carried out by the robot. To do this, a flange, which is attached to a robot flange, would be installed for the artery side instead of the hand grip. The movement of the needle cap, the sleeve and the two-part seat are then controlled electrically, hydraulically or pneumatically or by other drives.
The transplant portion can also be handled by a second robot arm for the suturing of the arteria mammaria interna. The handle with the needle carrier and the insertion aid would be flanged to a robot. The two-part seat would need to be pushed up manually or by yet another robot arm and pulled out along with the needles. The needle seat (two-part seat) is then put into the cradle by the robot, and the tightening and tying together is done manually.
Other applications of the present invention will become apparent to those skilled in the art when the following description of the best mode contemplated for practicing the invention is read in conjunction with the accompanying drawings.